Stopain Extra Strength Gel

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "B" on the other. Each tablet contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be applied directly onto the affected area. There is no requirement for bandaging after application.

For adults and children over 12 years of age, the medication may be reapplied if necessary; however, it should not be used more than four times daily.

For children aged 12 years or younger, it is advised to consult a physician before use.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse effects. Additionally, it is advised not to bandage tightly or use a heating pad in conjunction with the product, as this may lead to increased risk of complications or discomfort.

Warnings and Precautions

Contact with the eyes should be strictly avoided, as this product is intended for external use only. It is important to note that the product is flammable; therefore, it must be kept away from fire or flame to prevent any hazardous incidents.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, redness appears, or excessive skin irritation develops. These signs may indicate a need for further evaluation and management.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients or caregivers are advised to contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. It is crucial to avoid contact with the eyes, as this may lead to irritation or other complications. The product is intended for external use only, and users should exercise caution due to its flammable nature; it must be kept away from fire or flame.

In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor. Additionally, the presence of redness or excessive skin irritation should prompt immediate discontinuation of the product and a consultation with a healthcare professional.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Stopain Extra Strength Gel (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. For adolescents and adults over 12 years, the product may be reapplied if necessary, but should not exceed four applications within a 24-hour period.

It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Geriatric Use

There is no specific information regarding the use of Stopain Extra Strength Gel in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert text. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for healthcare providers to instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Patients should also be informed to stop using the product and consult a healthcare professional if they notice any redness or if excessive skin irritation develops. It is essential to emphasize that the product should be used only as directed.

Additionally, patients should be cautioned against tightly bandaging the area where the product is applied or using a heating pad during treatment. They should also be advised not to apply the product to wounds or damaged skin to avoid potential complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

Patients should apply the topical medication directly onto the affected area, with a maximum frequency of four times daily. It is important to avoid bandaging the area tightly or using a heating pad, and the product should not be applied to wounds or damaged skin. Clinicians should advise patients to avoid contact with eyes and to keep the product away from fire or flame due to its flammability.

Patients are counseled to discontinue use and consult a healthcare professional if their condition worsens, symptoms persist beyond seven days, redness occurs, or excessive skin irritation develops. Pregnant or breastfeeding individuals should seek advice from a health professional before use. Additionally, the product should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

Drug Information (PDF)

This file contains official product information for Stopain Extra Strength Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)